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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01217697




Registration number
NCT01217697
Ethics application status
Date submitted
7/10/2010
Date registered
8/10/2010
Date last updated
24/03/2017

Titles & IDs
Public title
Study of Abiraterone Acetate in Patients With Advanced Prostate Cancer
Scientific title
An Open Label Study of Abiraterone Acetate in Subjects With Metastatic Castration-Resistant Prostate Cancer Who Have Progressed After Taxane-Based Chemotherapy
Secondary ID [1] 0 0
212082PCR3001
Secondary ID [2] 0 0
CR017479
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Neoplasms 0 0
Genital Neoplasms, Male 0 0
Urogenital Neoplasms 0 0
Genital Diseases, Male 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Other cancer types
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cancer 0 0 0 0
Penile (penis)
Cancer 0 0 0 0
Testicular
Reproductive Health and Childbirth 0 0 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Abiraterone Acetate
Treatment: Drugs - Prednisone\Prednisolone

Treatment: Drugs: Abiraterone Acetate
Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.

Treatment: Drugs: Prednisone\Prednisolone
Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Confirmed prostate cancer
* Prostate cancer progression after previous chemotherapy as assessed by the investigator
* Received at least 1 but not more than 2 chemotherapy regimens for metastatic CRPC (at least one regimen must have contained a taxane such as docetaxel)
* Serum testosterone of less than 50ng/dL (less than 2.0 nM)
* Eastern Cooperative Oncology Group (ECOG) performance status of <=2 (ie, patients who do not have symptoms of prostate cancer and who are fully active, patients who have symptoms but are able to perform light work, or patients who are able to get around and are capable of taking care of themselves but are unable to carry out any work activities)
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Serious or uncontrolled co-existent non-malignant disease (including active and uncontrolled infection)
* Active or symptomatic viral hepatitis or chronic liver disease or any abnormal liver function assessed by liver function tests
* Clinically significant heart disease as assessed by the Investigator or uncontrolled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=95 mmHg)
* History of gastrointestinal disorders that may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction
* Known brain metastasis (ie, spread of cancer to the brain)

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
APPROVED_FOR_MARKETING
Data analysis
Reason for early stopping/withdrawal
Other reasons
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Actual
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Actual
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Recruitment in Australia
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- Garran
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- Heidelberg
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- Herston
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- Hobart
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- Kogarah
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- Kurralta Park
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- Liverpool
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- Randwick
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- Westmead
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- Wodonga
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- Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to collect additional safety information on abiraterone acetate administered with prednisone to patients with metastatic castration-resistant prostate cancer (CRPC).
Trial website
https://clinicaltrials.gov/study/NCT01217697
Trial related presentations / publications
Sternberg CN, Castellano D, Daugaard G, Geczi L, Hotte SJ, Mainwaring PN, Saad F, Souza C, Tay MH, Garrido JM, Galli L, Londhe A, De Porre P, Goon B, Lee E, McGowan T, Naini V, Todd MB, Molina A, George DJ; Abiraterone Global EAP Investigators. Abiraterone acetate for patients with metastatic castration-resistant prostate cancer progressing after chemotherapy: final analysis of a multicentre, open-label, early-access protocol trial. Lancet Oncol. 2014 Oct;15(11):1263-8. doi: 10.1016/S1470-2045(14)70417-6. Epub 2014 Sep 18. Erratum In: Lancet Oncol. 2014 Nov;15(12):e528.
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Address 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01217697